Director, QA & Regulatory Affairs - Clinical Research
Mass General Brigham
Mass General Brigham's NCRI unit seeks a Director of Quality Assurance and Regulatory Affairs to lead the organization’s QA programs across clinical trials, audits, and regulatory compliance. You will develop and implement QA strategies, supervise a team of 10+ staff, coordinate with regulators and sponsors, and ensure adherence to FDA and ICH-GCP guidelines. The role requires 8–10+ years in clinical research QA with leadership experience and a bachelor’s degree in a scientific discipline, plus #J-18808-Ljbffr Mass General Brigham
- Mass General Brigham NCRI seeks a Director of Quality Assurance and Regulatory Affairs to lead QA strategies, audits, and regulatory programs across clinical trials, ensuring FDA and ICH/GCP compliance... ...to advance clinical neuroscience research. #J-18808-Ljbffr Mass General...Suggested
- Mass General Brigham is seeking a Quality Assurance Manager for the Neurological Clinical Research Institute (NCRI) at 399 Revolution Drive, Boston. This role directs QA activities across clinical studies, ensuring adherence to GCP, regulations, and the NCRI Quality Management...Suggested
- Mass General Brigham's Neurological Clinical Research Institute seeks a Regulatory Coordinator to manage QA activities, SOP development, and regulatory compliance across NCRI and investigative sites. You will draft procedures, train staff on GCP, and support audits and...Suggested
$124.34k - $180.9k
...people, tech experts, researchers, and systems analysts... ...assurance and regulatory affairs for the organization,... ...Details (if applicable) Directors of the NCRI, the Director... ...MGH NCRI to conduct clinical trials under FDA and... ...Assurance and Regulatory (QA) team Develop,...SuggestedRemote workShift work- Mass General Brigham seeks a Director of Quality Assurance and Regulatory Affairs to oversee QA programs and regulatory compliance across the NCRI. You will lead audits, risk assessments, and investigations, collaborating with leadership to strengthen care quality and...Suggested
$250k - $300k
...Repertoire Immune Medicines is a clinical-stage biotechnology company harnessing... ...therapies designed to selectively expand regulatory T cells and reset the immune system.... ...is seeking an experienced Senior Director of Regulatory Affairs to serve as the company’s first...Temporary workWork experience placementWork at officeFlexible hours3 days per week- Mass General Brigham seeks a Regulatory Coordinator to manage QA and regulatory activities for NCRI, focusing on GCP compliance, audits, and site... ...to regulations. The role requires 3+ years in clinical research or QA, a scientific degree, and strong leadership and...Remote work
$63.25k - $102.6k
...people, tech experts, researchers, and systems analysts to... ...Manager and/or Project Director of a large global clinical study. This position has... ...agencies and other regulatory bodies. Collecting, reviewing... ..., Quality Assurance (QA) and Regulatory Affairs, the Regulatory...Work experience placementWork at officeRemote workShift work$166.4k - $249.6k
...Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for... ...Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical... ...acromegaly, and it continues to advance clinical and research programs in these areas. Vertex...Summer workRemote workFlexible hours2 days per week$170k - $180k
Director of Quality & Regulatory Affairs Department: Quality Employment Type: Full Time Location: Burlington,... ...care, and return to work. Published clinical research shows a clinically significant... ...Regulatory Affairs leads the global QA/RA function and is responsible for...Full time- ...business people, tech experts, researchers, and systems analysts to... ...quality assurance and regulatory affairs for the organization, ensuring... ...Job Details (if applicable) Directors of the NCRI, the Director of... ...the MGH NCRI to conduct clinical trials under FDA and institutional...Remote work
- Sarepta Therapeutics is seeking a Director, Corporate Quality to lead GCP/GLP QA across Clinical Development and Real-World... ...Clinical, Pharmacovigilance, and Research teams to uphold patient safety... ...external and internal audits and regulatory inspections. #J-18808-Ljbffr...
- ...developing and maintaining the Regulatory Sciences compliance framework... ...product lifecycle from Good Clinical Practice (GCP) through Good... ...collaboration accountable owners QA partners. Ensure appropriate... ...’s degree in Regulatory Affairs, Life Sciences, Pharmacy, or...Full timeTemporary workLocal areaFlexible hours
$207k - $253k
...ensure we have the right talent, at the right time, in the right way. The Director of Regulatory Affairs CMC provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post-approval submissions,...Minimum wageFull timeWork at officeLocal areaFlexible hours3 days per week- ...Summary The Senior Director, Regulatory Affairs leads and coordinates regulatory interactions and submission execution for ARTBIO’s clinical-stage radiopharmaceutical programs. This role... ...works cross-functionally to translate research and development data and strategy...Contract work
- ...company dedicated to drug discovery, clinical development, and commercialization... ...study, X-TOLE3, which would support regulatory submissions outside the U.S., and the... ...This position reports to the Executive Director, Regulatory Affairs, CMC, and will be based out of...Temporary workWork at officeRemote work2 days per week
$215k - $235k
...Arbor Biotechnologies, a clinical stage, next-generation gene editing company based in Cambridge, MA, is advancing a portfolio... ...like you then please read on! About the Role: The Director of Regulatory Affairs is responsible for leading regulatory strategy and...$171.75k - $286.25k
...development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision... ...additional experience ex US and EU preferred. Experience with clinical trial and licensing requirements for Precision Medicine and Digital...Temporary workLocal areaRemote work- ...Job title: Medical Director Pulmonary ~ Location: Cambridge... ...Sanofi Immunology Medical Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on... ...Outcomes, Safety, and Clinical Research including Phase IIIB-IV...Local area
- ...of Position:Looking for an associate or director-level subject matter expert to build clinical operations compliance while upholding our... ...cross-functional team members within Regulatory, Quality, Data Sciences, Clinical Research, Pharmacovigilance, and other key cross-...Work at officeFlexible hours
- ...GroupContact: ApplicationsEmail: ****@*****.*** OverviewPlanet Pharma’s clinical-stage biotechnology client is seeking an experienced Senior Director of Regulatory Affairs to serve as the company’s first internal Regulatory Affairs hire and senior...Work at office3 days per week
$195k - $330k
Who we are:Kymera is a clinical-stage biotechnology company pioneering the field... ...make an impact:Act as the global regulatory strategy lead for Kymera’s IRF5... ...degree preferred but not required.Director: 8-10 years of Regulatory Affairs experience. Senior Director: 10-12...Flexible hours$210k - $320k
...cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing CMC and Quality related health authority agency correspondence...Full timeShift work3 days per week1 day per week- ...in 1947, Pulpdent Corporation is an industry-leading dental research and development (R&D) and manufacturing company. Pulpdent’s... ...practices, visit pulpdent.com. Job Summary The Head of Regulatory Affairs will lead and evolve Pulpdent’s global regulatory strategy across...
$227.9k - $308.3k
Overview:The Senior Director, Global Pharmacovigilance Quality Assurance... ...direction for the GVP QA function and provides independent... ...excellence, and long-term regulatory compliance.This role can be based... ...Safety, Quality, Regulatory, Clinical, Commercial, and enterprise...Full timeTemporary workLocal areaRemote workFlexible hours- ...Director, Regulatory Affairs, Global Labeling Strategy (US) Overview The Director of Global Labeling... ...plans by partnering early with Clinical Development, Biostatistics, Medical,... ...Use approved AI tools and advanced research approaches responsibly to accelerate...Local area
$216.3k - $324.5k
...Job Description Senior Director, Regulatory Transformation & Innovation Job Summary... ...initiatives across Global Regulatory Affairs (GRA). This Senior Director will define... ...acromegaly, and it continues to advance clinical and research programs in these areas. Vertex...Summer workRemote workFlexible hours2 days per week3 days per week- Job Description Position Overview The Quality & Regulatory Affairs Manager is responsible for ensuring organizational compliance with applicable... ...Structure This position reports to the: President Director of Engineering Director of Operations #J-18808-Ljbffr Energy...Work at office
- ...in ensuring the highest standards of food safety, quality, and regulatory compliance across all operations. This position is responsible for... .... Provide corrective action reports to FSQA leadership. Oversee QA laboratory programs and equipment (pest control, Listeria...Local area
- ...quality oversight of global PV systems from Cambridge, MA, with remote engagement across international teams.The role reports to the Director of Global PV Quality Assurance and focuses on GVP compliance, audit programs, inspection readiness, and cross-functional...Remote job
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